Responsible to the CRU Research Practice Manager for the day-to-day operations of the CRU cluster or delegated CRU responsibilities associated with the Site-Based Research group's participation in clinical research studies as an investigative site. Ensure that CRCs and designated research personnel are performing study activities in accordance with Good Clinical Practice (GCP), Duke policy and regulatory requirements using Standard Operating Procedures (SOPs) and periodic monitoring.

Work Performed

Serves as assistant to RPM and includes divisional or cluster lead within a CRU with oversight of peers and delegation of project related tasks to others on the study, knowledgeable of various funding sources including industry or federal grants. Ensure that staff are appropriately trained. Participate in assessing the feasibility of new studies with cluster, division, area of disease studied. Ensure that new studies are initiated appropriately and monitor the performance and progress of ongoing studies. Ensure appropriate coordination of IRB submissions, participant recruitment, screening, consent and enrollment, data collection, safety reporting, drug accountability, and record retention.

Supervise the day-to-day operations of the CRU related to study conduct including IRB submissions and renewals; protocol initiation; patient recruitment, screening, consent, enrollment and follow-up; data collection; safety reporting; drug accountability; study close-out and record retention. Review and supervise activities performed by study coordinators and other research staff involved in study conduct and ensure that activities are performed in accordance with Good Clinical Practice standards, Duke policies and procedures, and applicable regulatory requirements.

Plan and coordinate staffing needs based on current and future workload requirements.
Screen, interview and hire study coordinators and other research staff in conjunction with faculty input.

Coordinate and assign study coordinators and other research staff to individual studies and research related activities.

Supervise study coordinators and other research staff and perform various personnel actions including, but not limited to, hiring, performance planning and evaluation, scheduling and work assignments, disciplinary action, promotions and transfers.

Conduct regular meetings with study coordinators and other research staff. Ensure that staff are kept abreast of CRU, departmental and institutional activities, goals, and policies and procedures.

Plan and coordinate orientation and ongoing training for study coordinators and other research staff. Ensure that current training records and required certifications are maintained.

Evaluate the feasibility of new studies including staffing and budgetary requirements, clinical and logistical considerations, and competing studies. Provide input regarding study selection.

Ensure appropriate planning and coordination prior to the approval and initiation of new protocols; including the accurate and timely development of the charge assignment grid based on the schedule of events and protocol. Assist in budget/contract negotiations with sponsors.

Monitor the status of start-up timelines for new studies including IRB approval and contract execution. Monitor the progress of ongoing studies including enrollment, data collection, and close-out

Serve as an expert resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements and problem-solving related to clinical, logistical, financial and regulatory issues.

Review the finances of ongoing trials on a monthly basis in conjunction with the CRU Director, PIs, Financial Manager and study coordinators. Facilitate efforts to address budget-related issues.

Assist PIs, study coordinators and research staff in the development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.

Participate in audits conducted by the CTQA group, sponsors, and regulatory authorities. Review and respond to audit reports, and develop and implement corrective action in a timely manner when problems in research practice are identified.

Conduct CRU QA audits for division or cluster.

Ensure that the CRU has up-to-date standard operating procedures, that staff are knowledgeable regarding SOPs, and that all activities are conducted in accordance with SOPs.

REPORTING RELATIONSHIP The Associate RPM will report to the Research Practice Manager.

Required Qualifications at this Level

Education/Training

Allied Health degree or Associates degree in Clinical Trials Research and 8 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred.
OR
RN or Bachelor's degree and 6 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred.
OR
Master's degree and 4 years of related experience, with at least two years in a research setting. ACRP or SOCRA preferred.

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Essential Physical Job Functions:

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Education

Allied Health degree or Associates degree in Clinical Trials Research and 8 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred.OR RN or Bachelor's degree and 6 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred.OR Master's degree and 4 years of related experience, with at least two years in a research setting. ACRP or SOCRA preferred.